Kornimate/medical-research-clean huggingface dataset:
assessment of return to work and functional results of french military personnel after ankle ligamentoplasty

Conditions: Ankle Sprains

Summary: in the general population, ankle sprains are one of the most common injuries, accounting for approximately 20% of all sports injuries and the most frequent reason for trauma consultation (4 to 7% of admissions to emergency departments in france). the most frequent complication after an episode of ankle sprain is the development of chronic ankle instability (5 to 40% of the patients). chronic ankle instability is defined by a history of at least one significant ankle sprain with subsequent perception of an abnormal ankle by the patient, associated with various symptoms including: recurrent sprains, repeated episodes of ankle "slippage", pain, episodes of swelling, difficulty and apprehension when walking on uneven surfaces with a decrease in the functional capacity of the ankle or restriction of activity. in the military population, ankle sprains account for 18.60% of on-duty injuries, and epidemiologic studies report an incidence of 45.14 to 58.40 sprains per 1,000 person-years. a 2019 study in a population of french military paratroopers found a prevalence of chronic ankle instability of 43.1% after an ankle sprain. chronic ankle instability leads to a loss of operational skills in french soldiers, since it results in a score of 4 for the letter "i" (pelvic girdle and lower limbs) in the sigycop military medical profile. the treatment of chronic ankle instability after failure of rehabilitation consists in ligamentoplasty, conservative or not, in order to restore an external ligament plane and stabilize the ankle. for open techniques, the median time to return to sport after ligamentoplasty is 4.7 months. in the series by lee et al, which studied more specifically the return to sport in high-level athletes, 83.3% of athletes had returned to competitive sport at 4 months and 100% at 8 months. management of chronic ankle instability by ligamentoplasty may allow the soldier to regain his operational ability (sigycop score i=2).


Eligibility criteria:
inclusion criteria: * military personnel, * primary ankle ligamentoplasty surgery between january 2015 and december 2021, * sufficient french language reading/writing level (elementary school level). exclusion criteria: * ankle ligament surgery after a first failure.

Keywords: ligamentoplasty
neurotoxicity evaluation of beta-lactams in intensive care unit and identification of the risk factors

Conditions: Neurotoxicity; Sepsis; Beta Lactams; Therapeutic Drug Monitoring; Critical Care; Acute Kidney Injury

Summary: beta-lactams are the most prescribed antibiotics in intensive care units. the lack of linearity between the dose administered and the exposition due to the very high variability of the pharmacokinetics in critically ill patients requires that the treatment be adapted on a case-by-case basis depending on the drug serum concentration. however, maximum concentrations not to be exceeded in order to limit beta-lactams toxicity are generally unknown. the main toxic risk of beta-lactams in intensive care is indeed neurological, but the neurotoxicity is probably underdiagnosed due to the variability of the signs observed, their time to onset, and confounding factors. apart from recommendations for dose adjustment in the event of renal insufficiency, the procedures for the proper use of beta-lactams in intensive care are poorly established. the study presented here aims to assess the impact of the neurotoxic risk of beta-lactams in intensive care based on therapeutic drug monitoring, and thus to improve beta-lactam safety in critically ill patients. this is a prospective cohort study evaluating change in neurological status of patients admitted to the icu and treated with a beta-lactam antibiotic with therapeutic drug monitoring. neurological evaluation and scoring (glasgow scale, cam-icu, richmond agitation-sedation scale) and beta-lactam serum concentration assay are performed together 2 to 3 times a week.


Eligibility criteria:
inclusion criteria: * patients admitted to the icu * treatment initiation by an antibiotic of the beta-lactam class * beta-lactam therapeutic drug monitoring exclusion criteria: * any neurological disorder already present at admission * patients on mechanical ventilation who presented a neurological disorder before being intubated and sedated

Keywords: neurotoxicity sepsis beta lactams therapeutic drug monitoring critical care acute kidney injury
sustained aeration of infant lungs trial

Conditions: Preterm Birth; Extreme Prematurity

Summary: this study is a 2-arm randomized, controlled, multi-center clinical trial to determine which of two strategies at birth are best to optimally aerate the lung of preterm infants. specifically we will determine in 600 infants of 23-26 weeks gestational age (ga) requiring respiratory support at birth which of two lung opening strategies - either a standard peep/cpap of 5-7 cm h2o in the delivery room (dr), as compared to early lung recruitment using sustained inflation (si) in the dr, will result in a lower rate of the combined endpoint of death or bronchopulmonary dysplasia (bpd) at 36 weeks gestational age. hypotheses: 1. early lung recruitment with si superimposed upon standard peep/cpap in the dr will reduce the need for mechanical ventilation in the first seven days of life, and reduce need for surfactant use; and 2. a policy of dr si on standard peep/cpap recruitment will confer better outcomes at 36 weeks post-menstrual age (pma) than standard peep/cpap

the sail trial aims to provide evidence for changing policy or standard of care. the context of this trial is an unacceptable rate of poor long-term outcomes of preterm infants born as extremely low gestational age newborns (elgan) \<1000 g birthweight (bw), but especially for those born between 23-26 weeks' gestational age (ga). such infants are the most vulnerable and immature in all organ systems, including the lungs and the brain. these infants are at high risk of death and bronchopulmonary dysplasia (bpd) during their initial hospitalization, neurodevelopmental impairment (ndi) and pulmonary problems in infancy and childhood. the sail trial focuses on facilitating the difficult transition of these most vulnerable infants from a liquid filled in-utero lung to an ex-utero air-filled lung. sustained inflation (si) is a promising delivery room (dr) intervention, with evidence of short-term efficacy with minimal risk of additional harm beyond current standard accepted newborn resuscitation program (nrp) guidelines. this protocol proposes a fully informed consenting procedure. we propose to evaluate the impact of a si in the dr on the need for mechanical ventilation in the first week of life which would also impact mortality rates and the incidence and severity of bpd.

Eligibility criteria:
inclusion criteria: * gestational age (ga) at least 23 weeks but less than 27 completed weeks by best obstetrical estimate * requiring resuscitation/respiratory intervention at birth -"apneic, labored breathing, gasping" (as defined in nrp 2011 aap 6th edition p.45) exclusion criteria: * considered non-viable by the attending neonatologist * refusal of antenatal informed consent * known major anomalies, pulmonary hypoplasia * mothers who are unable to consent for their medical care and who do not have a surrogate guardian will not be approached for consent

Keywords: neonatal resuscitation extreme low gestational age newborn (elgan) delivery room continuous positive airway pressure (cpap) positive pressure ventilation (ppv) sustained inflation
a clinical study for the development of a device (lovelace) for antepartum fetal monitoring

Conditions: Fetal Monitoring

Summary: bloomlife lovelace ft is a non-invasive, wireless, external measurement system used to measure accelerometer and electrophysiological signals on pregnant women with a singleton pregnancy, by acquiring biopotential signals from abdominal surface electrodes. in this study, bloomlife lovelace ft is used to collect the dataset needed for the development of a future product (bloomlife lovelace) for the monitoring of fetal heart rate, maternal heart rate and uterine activity.


Eligibility criteria:
inclusion criteria: * pregnant woman ≥ 18 years old * gestational age greater or equal to 24 weeks and 0 days * singleton pregnancy * ability to read and understand dutch * willingness to participate in the study exclusion criteria: * implanted pacemaker or any other implanted electrical device * history of allergies to skin adhesives * irritated or lesioned skin at the bloomlife lovelace ft electrodes locations * contraindication to the use of ctg based on physician's decision (e.g. due to preterm contractions)
immune modulation from trichuris suis

Conditions: Crohn Disease; Ulcerative Colitis; Intestinal Helminthiasis

Summary: mucosal immunology during helminth infection

the present study investigates the effects of trichuris suis on human mucosal and systemic immunity in a single self-infected individual.

Eligibility criteria:
inclusion criteria: * the included volunteer is a researcher within parasitology with main focus on trichuris trichiura and trichiura suis. he planned to infect himself and contacted our department with the purpose of being monitored during this infection for safety (medical supervision) and research reasons. the only clinical criterion for his inclusion in the study was that he was healthy. exclusion criteria: -
surgical result of pterygium extended removal followed by fibrin glue assisted amniotic membrane transplantation

Conditions: Pterygium; Recurrence

Summary: the treatment of pterygium is still quite controversial. previous studies using a large incision for pterygium excision and a large graft and has reported a very low recurrence rate with the p.e.r.f.e.c.t. technique. however, the p.e.r.f.e.c.t. technique is a relatively lengthy procedure and may not be suitable for patient with limited conjunctival reserve. thus, we try to evaluate the final outcome of a sutureless amniotic membrane transplant technique combining the extended pterygium excision in hope to avoid the complication of the p.e.r.f.e.c.t. for pterygium technique.

the treatment of pterygium is still quite controversial. there is a lack of consensus in the ophthalmological community about the optimal surgical management of pterygia. the main challenge to successful surgical treatment of pterygium is recurrence, evidenced by fibrovascular growth across the limbus onto the cornea. previous studies using a large incision for pterygium excision and a large graft and has reported a very low recurrence rate with the p.e.r.f.e.c.t. technique. however, the p.e.r.f.e.c.t. for pterygium technique is not that perfect since it is a lengthy procedure, requires meticulous handling of tissue, and is associated with significant postoperative pain and, frequently, transient diplopia. therefore, we try to evaluate the final outcome of a sutureless amniotic membrane transplant technique combining the extended pterygium excision in hope to avoid the complication of the p.e.r.f.e.c.t. for pterygium technique. this sutureless technique with the tissue glue may promote increased clinical use of amniotic membrane patch by alleviating patients' pain and shortening surgical time.

Eligibility criteria:
inclusion criteria: * patient with pterygium * operated by single surgeon (chen, wei-li) exclusion criteria: * follow-up time less than 12 months * age less then 18 year-old

Keywords: pterygium recurrence
pre and post muscular fatigue - drop-jump test

Conditions: Motor Control

Summary: many studies have related the presence of dynamic valgus with several musculoskeletal injuries of the hip, knee and ankle. the weakness of the hip abductors is cited as one of the factors linked to this poor dynamic alignment of the lower limb, however, motor control can also be one of the factors responsible for the poor alignment of the lower limbs.


Eligibility criteria:
inclusion criteria: women aged between 18 and 29 years body mass index between 18.5 and 24.99 sedentary irregularly active no pain no injuries (hip, knee, foot, ankle or lumbar spine) no neurological sequelae exclusion criteria: pain during the test

Keywords: rehabilitation lower limb-muscle alignment, sequence
distribution of ventilation, respiratory drive and gas exchange: measurements and monitoring

Conditions: Pulmonary Disease; Respiratory System Abnormalities; OSA; Respiratory Failure

Summary: respiratory physiology involves a complex interplay of elements including control of breathing, respiratory drive, pulmonary mechanics, distribution of ventilation and gas exchange. body position may also play an important role in respiratory mechanics. while effective methods exist for measuring these variables, they are typically measured in isolation rather than in combination. in pulmonary disease, decreasing mechanical stress and strain and optimizing transpulmonary pressure or the distending pressure across the lung, minimizing overdistention and collapse are central to clinical management. obesity has a significant impact on pulmonary mechanics and is a risk factor for obstructive sleep apnea (osa). however, our understanding of these elements is limited even in the general population. the investigators plan to use various validated methods to assess control of breathing, respiratory drive, distribution of ventilation and gas exchange to obtain a better understanding of underlying physiologic signatures in patients with and without obesity and the role of posture/position, with a secondary analysis comparing participants with and without obstructive sleep apnea.


Eligibility criteria:
inclusion criteria: * 18 years or older * non-smokers exclusion criteria: * \<18 years old * significant history of pulmonary disease * chest wall, anatomical, physical abnormalities, skin integrity issues precluding placement of electrode belt in direct contact with skin * skin integrity issues precluding placement of nose clips, or transcutaneous carbon dioxide monitoring * inability to form a seal around a mouthpiece * known esophageal strictures, webs, or varices (if esophageal manometry to be included) * known platelet count \< 100,000 (if esophageal manometry to be included) * on therapeutic anticoagulation (if esophageal manometry to be included) * known multidrug resistant (mdr) pulmonary infection * non-english language speakers * chronic hypoxemic respiratory failure * confirmed or suspected intracranial bleed, stroke, edema * active implants (i.e. implantable electronic devices such as pacemakers, cardioverter defibrillators or neurostimulators) or if device compatibility is in doubt * pregnant or lactating patients as safety and efficacy for use of eit in such cases has not been verified
open-label drug interaction study evaluating desvenlafaxine succinate sustained release (dvs sr) 100mg on the pharmacokinetics of tamoxifen when coadministered to healthy post-menopausal female subjects

Conditions: Pharmacokinetics

Summary: the goal of this study is to evaluate the effect of multiple doses of desvenlafaxine sr on the pharmacokinetics of tamoxifen and endoxifen when coadministered to healthy post-menopausal female subjects. this study will also evaluate the safety and tolerability of desvenlafaxine sr and tamoxifen when coadministered to healthy post-menopausal female subjects.


Eligibility criteria:
inclusion criteria: * healthy post-menopausal female subjects, at least 45 years of age, with confirmed post-menopausal status * hysterectomized subjects * body mass index (bmi) less than or equal to 34.0 kg/m2 * nonsmoker or smoker of fewer than 5 cigarettes per day as determined by history * an informed consent document signed and dated by the subject exclusion criteria: * history of significant blood, kidney, endocrine, lung, gastrointestinal, heart, liver, psychiatric, neurologic, or allergic disease * presence or history of deep vein thrombosis or transient ischemic attack * history of seizure disorder * presence or history of glaucoma or increased intraocular pressure * allergy to or unable to tolerate tamoxifen, desvenlafaxine, or venlafaxine * history of substance abuse within 1 year of study * a positive urine drug screen * treatment with an investigational drug within 30 days * consumption of grapefruit or grapefruit related citrus fruits * 12 lead ecg demonstrating qtc \>450 msec at screening * pregnant or nursing females * use of prescription or nonprescription drugs and dietary supplements * history of sensitivity to heparin or heparin induced thrombocytopenia * severe acute or chronic medical or psychiatric condition or laboratory abnormality * use of cyp 2d6 inhibitors and cyp 3a4 inhibitors/inducers

Keywords: pharmacokinetic safety and tolerability genetic testing cyp 2d6
sensory augmentation methods in stroke

Conditions: Stroke

Summary: many chronic stroke survivors have poor walking balance, contributing to an increased risk of falls and fear of falling. one factor contributing to these balance deficits is a reduced ability to place the feet appropriately when walking. this study investigates whether enhancing the sensory information available to chronic stroke survivors while they walk improves their foot placement accuracy and balance.

the objective of this project is to test a method of providing real-time augmentation of hip proprioceptive feedback during post-stroke walking. the sensory information available to participants will be augmented by providing vibration of the hip abductor musculature that is scaled to the near-real-time mechanical state of their body. the central hypothesis is that augmented proprioception will improve participants' perception of their body's motion, thus increasing the mechanics-dependent modulation of foot placement, an important gait stabilization strategy. this clinical trial will establish the safety, feasibility, and efficacy of a rehabilitation intervention centered on repeated exposure to sensory augmentation during gait. specifically, participants in the experimental group will complete training sessions twice a week for four weeks in which they receive sensory augmentation during \~30 minutes of treadmill walking. participants in the activity-matched control group will perform the same task, except the hip vibration will be randomly delivered, not linked to the body's actual mechanical state. changes in walking balance and foot placement accuracy will be quantified over the course of the intervention.

Eligibility criteria:
inclusion criteria: * experience of a stroke 6 months prior to participation * gait speed of at least 0.2 m/s * ability to walk on a treadmill without a cane or walker * provision of informed consent exclusion criteria: * evidence of cerebellar damage * resting blood pressure higher than 220/110 mm hg * history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living * preexisting neurological disorders or dementia * legal blindness or severe visual impairment * history of dvt or pulmonary embolism within 6 months * uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions * orthopedic injuries or conditions (e.g. joint replacements) in the lower extremities with the potential to alter the gait pattern

Keywords: stroke gait
database of interstitial lung diseases

Conditions: Interstitial Lung Diseases

Summary: the cause of most interstitial lung diseases (ilds) is still unknown. further research, for example to determine predisposing genetic factors, is therefore needed. a database with relevant clinical data and dna/serum samples of ild patients could facilitate future research on the cause of ilds.

protocol title: 'registration of clinical data and dna of patients with interstitial lung disease (ild)' rationale: the etiopathogenesis of most interstitial lung diseases (ilds) is still unknown. further research, e.g. to determine predisposing genetic factors, is therefore needed. a database with relevant clinical data and dna/serum samples of ild patients could facilitate future research on the etiopathogenesis of ilds. objective: availability of relevant clinical data and dna/serum samples of ild patients in a database. those data can be used for future research. study design: a prospective observational study study population: patients diagnosed with ild attending the pulmonology department in participating hospitals. intervention: a blood sample is taken from each patient. furthermore, additional information is collected from the medical file. main study parameters/endpoints: dna and serum sample, demographic variables, medical information, occupational history and hobbies. nature and extent of the burden and risks associated with participation, group relatedness: two tubes of blood will be drawn from the patients. the risks of drawing blood from a vein are minimal.

Eligibility criteria:
inclusion criteria: * diagnosis of an ild, as stated by the american thoracic society (ats)

Keywords: lung disease, interstitial sarcoidosis pulmonary fibrosis
study to assess the seroprevalence of anti-tat antibodies in hiv-infected patients

Conditions: HIV Infection

Summary: tat is a key hiv regulatory protein produced very early after infection, prior to virus integration, and necessary for viral gene expression, cell-to-cell virus transmission and disease progression. previous studies in natural hiv infection, indicated that the presence of a tat-specific immune response correlates with a lower incidence and reduced risk of progression to aids as compared to anti-tat negative individuals suggesting that an immune response to tat may exert a protective role and control the progression to aids in vivo. on the basis of the above mentioned consideration, the present study was directed at investigating the seroprevalence of anti-tat antibodies in hiv-infected south african patients.

this is an observational, cross-sectional study aimed at assessing the frequency, magnitude and quality of the anti-tat antibody response in both antiretroviral (arv)-treated and treatment-naïve hiv-infected south african adults, and at exploring the correlation between the presence of anti-tat antibody response and the immunological status of participants as well as with the presence of co-infections such as hbv, syphilis and hpv (the latter only for female participants). the study has involved 531 participants and provided important information for the planning, design and conduction of future therapeutic clinical trials with the tat-based hiv vaccine in south african individuals. this study is conducted in the frame of the government-to-government cooperation program n. aid 8421, funded by the italian ministry of foreign affairs-directorate general for development cooperation (mae-dgcs) and jointly implemented by the italian istituto superiore di sanita' (iss) and the south african department of health in collaboration with the south african aids vaccine initiative of the medical research council (mrc-saavi)

Eligibility criteria:
inclusion criteria: * hiv-infected individuals aged 18-45 years participants enrolled into the arv-treated group must have been on treatment for not less than 3 months. exclusion criteria: * unwillingness to consent to study inclusion

Keywords: hiv haart